Healthcare Industry News:  neuromodulation 

Devices Cardiology

 News Release - May 13, 2010

FREEDOM Trial Demonstrates CRT Response Rates Using St. Jude Medical Optimization Feature are Comparable to Echo Optimization

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced results of the FREEDOM trial during the late breaking clinical trial presentations at Heart Rhythm 2010, the Heart Rhythm Society’s 31st Annual Scientific Sessions. The trial demonstrated that the QuickOpt® optimization feature available in St. Jude Medical cardiac resynchronization therapy (CRT) devices produces an equivalent response rate in CRT patients as optimization using echocardiography (echo).

FREEDOM (A Frequent Optimization Study using the QuickOpt Method) was a randomized, controlled trial studying the effects of frequent optimization of atrial-ventricle (AV) and ventricle-ventricle (VV) delays in CRT patients, comparing QuickOpt optimization to the current standard of care, including echo optimization and other methods. The FREEDOM trial was the largest trial to-date evaluating efficacy of CRT device optimization, enrolling 1,647 patients. The primary endpoint of the FREEDOM study was a heart failure clinical composite score (CCS), which classifies patients as worsened, unchanged or improved at their last follow-up.

“This trial demonstrates that the QuickOpt feature in St. Jude Medical devices is an efficient, comparable replacement for expensive and time consuming echo optimization,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “The study also reinforced that we have additional opportunities and research to do in order to improve the response rate to CRT therapy, enabling more patients to benefit from this life-extending and life-improving therapy.”

The FREEDOM trial did not study degree of improvement, nor did it determine whether optimization is more useful in CRT non-responders. In the St. Jude Medical sponsored RESPONSE-HF (Response of Cardiac Resynchronization Therapy Optimization With V-V Timing in Heart Failure Patients) trial, also being presented at Heart Rhythm 2010, a higher percentage of CRT non-responders became responders when bi-ventricular pacing with V-V optimization was utilized, rather than simultaneous pacing alone.

“Considering the totality of available data, CRT optimization may benefit most those patients considered to be non-responders to treatment,” said Dr. William T. Abraham, director, Division of Cardiovascular Medicine at The Ohio State University and co-principal investigator of the FREEDOM trial. “In this regard, FREEDOM supports the addition of QuickOpt to our armamentarium of tools available to optimize the delivery of CRT.”

Additionally, the FREEDOM trial studied the effect of optimization on clinical response, but did not study the effects of optimization on left-ventricular (LV) reverse remodeling. The recently launched Optimise CRT (Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy) trial, sponsored by St. Jude Medical, is a randomized, controlled trial that will study the effect of optimization on LV reverse remodeling.

Cardiac resynchronization therapy - delivered in an ICD or a pacemaker - resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Over five million Americans have heart failure with 670,000 new cases diagnosed each year. The estimated direct and indirect cost of heart failure in the United States for 2009 was $37.2 billion.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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